I think drugs should be used only as FDA approved. And as we all
know that can be risky at times!.

Skeptical RN

12/05/12

So now ethical considerations and patient safety are trashed in the name of "free speech"? Pharm reps
can just go to the doctor and tell them any old lie they want-- and in so doing, they get the full
protection of the US government? Really? What a precedent: Think about the implications throughout
everything in our government....this establishes a precedent that is extremely far reaching. There are
persons who are incarcerated who now have grounds for appeal. From Madoff on down...now anyone can
lie about anything and our government protects their right to do so, and in fact condones it..

Stan Racansky

12/05/12

Will this allow me also to expose in effectiveness of prescription drugs. There is not one prescription drug in the
market which actually works for intended purposes but all of them have devastating negative side effects..

sdemetri

12/05/12

There is an element of "corporate speech" that includes a fallacious notion of corporate personhood and
the granting of constitutional free speech to that corporate "person." Supreme Court Justice Stevens
alluded to this in his dissent of the Citizens United decision. It would be interesting to know what part
this notion played in this decision. The profit motive of these corporate persons is not always, indeed,
ever, conscientious and allowing corporations to police their own motives is a slippery slope that does
not bode well for actual flesh and blood persons. Making settlements more difficult for grievous,
negligent injury to real persons holds no gratification for the soulless corporate person, but to it's
officers and shareholders... such power is very gratifying I'm sure....

MedicineBear

12/05/12

If non-FDA-approved claims can be made about untested uses of
dangerous drugs, can non-FDA-approved claims now be made about the
benefits of natural vitamins, herbs, and supplements? Or are
chamomile tea and vitamin C (and other natural supplements whose
efficacy and safety is demonstrated by their effective usage for
millenia) too &quot;dangerous&quot; for free speech that covers carte blanche
date-rape drug mongering?.

Ken Pilgreen, MD

12/05/12

If we don't use medications for off-label purposes, then 1/2 of
patients go untreated for difficult problems, especially in clinical
neuroscience. Many times medications have good science for these
uses, even clinical trials, but the billion dollar plus that it
takes for approval for a new indication with potentially less return
for that indication keeps companies from going for that. Physicians
must know pharmacology very well and match it to a deep
understanding to pathophysiology. I see some very "concrete"
comments already posted regarding this news report. I think it is
potentially a positive thing and not back to "snake oil". The CYA
with a Black Box appearing for almost every drug is what the FDA is
about..

CH

12/05/12

I agree with Dr. Nissen..

a m

12/05/12

This isn't
necessarily about
using drugs for
off-label purposes
(Ken). This is about
drug companies
deceptively
marketing and
promoting drugs for
problems with little
to no testing (of
which the consumer
has no idea and can
usually get just by
asking their
doctor.) Do we
really want drug
reps free to say
whatever they
personally think a
drug is good for?
Anyone who thinks
that will end up
well...I have a
miracle pill to sell
you..

Concerned Researcher

12/05/12

While this may have some dangerous implications, the off-label use
of drugs and medical devices has always been allowable by
physicians based upon good medical judgement. Most medications
have not been tested in children until very recently and a huge
percentage of prescriptions of drugs for children are off-label.
If companies cannot disperse their knowledge concerning emerging
information obtained from off-label use, patients will suffer the
consequences. The FDA interprets any acknowledgement of off-label
use of a product by a company as off-label use, including
communication of complications being observed. I think the
perception that manufacturers are concerned only about the bottom
line and not patient safety is misguided. Physician education
about the benefits, appropriate usage, and complications of off-
label usages is critical to patient safety. Companies can be
hamstrung and patients adversely affected if proper usage and
complications cannot be communicated. A medical device off-label
usage a few years ago caused complications that became known to the
physicians involved and was reported to the company but the company
could not warn its customers and the FDA only issued a warning
several years later..

RB PharmD

12/05/12

There must be freedom, within reason, to use drugs for off label
indications. Otherwise, aspirin would not be able to be used for
patients having heart attacks. There is very good scientific
evidence showing aspirins positive effect in treating these
patients. However, I do have extreme concern over companies and
sales representatives being allowed to market drugs for indications
that either the companies have not taken the time to study or where
the studies have been done and the results were not enough to get
the FDA to approve the drug for the particular indication.
Currently, any medical professional can call or write for
information from a company's medical affairs office and get
information on off label uses. So, the information is readily
available if it is sought. The problem with this decision is that
the sales representatives, if left to their own devices, can, and
in some cases will, promote their wares for almost anything to
medical professionals who either don't have the time or refuse to
take the time to stay current on drugs who then are "forced" to get
their drug information from sales representatives. If this
decision is allowed to stand, used car salesman will then be able
to say they are no longer last in the trust ladder of professions.
Pharmaceutical reps will easily move into that position. We should
be promoting evidence based practice. This is a big step backward..

Taava

12/05/12

I've been a pharmacist for 20 years. The first thing I learned when I entered the workplace is most drugs are crap.
It seems the only good drugs left are anticoagulants and meds for the heart and blood pressure., oh, and insulin for
diabetics. I'm leaving the profession and "healthcare" in general. I can barely take care of myself let alone patients.
And with the advent of this development, I would rather bag groceries than risk killing and maiming someone by
dispensing drugs off-label. Obamacare didn't ruin healthcare. We did. I don't know how anyone in the business can
get a good nights sleep anymore. Oh, and prescription sleep meds are crap, too. Good luck to those who choose
to stay. I'll take bankruptcy over golden handcuffs..

janice jacobovitz

12/05/12

While the marketing of these drugs has just been given a boost with
the Appeals Court decision, I didn't see anything in this article
requiring Insurance Companies to pay for the off-label use of
prescription drugs. Most insurance plans have Formularies that say
whether they will allow payment for the drug and what the member
liability is. In many cases these Formularies exclude off-label
use from reimbursement, which means that the consumer has a
potential risk for payment from their own funds. Most of these
drugs are not inexpensive..

KAC RN

12/05/12

First: Stan, have you ever had an infection that required
antibiotics. Enough said. Take a breath. Regarding the topic at
hand, I don't really think this is about drug reps selling to
physicians and institutions. Drug reps (and I have friends who
are) pretty much always have two fingers crossed behind their backs
when they are selling their products. I am much more concerned
about a ramping up of the endless stream of advertisements - TV,
radio and print - directed at the general public. As it is,
there's a steady stream of people queuing up in their doctor's
offices to demand to latest and greatest shiny new thing advertised
in the media for the ailment they have or think they have. When
did false/misleading advertising become free speech?.

Henry Bussey, Pharm.D.

12/05/12

As I read this, it prohibits the dissemination of incorrect
information just as before. Over the last few years, speakers for
any industry-sponsored CME talks could only discuss what is in the
FDA approved package insert. The speaker had to act like he/she did
not know about the most recent and exciting research. The drug
Inderal (propranolol) was probably the #1 drug for treating high
blood pressure BEFORE it was approved for that purpose by the FDA.
The pharmacology made sense and studies showed that it worked and
had fewer adverse effects than other agents, but the company had not
yet secured FDA approval for that indication. Under the existing
regulations, neither a drug company rep nor an informed educational
speaker in a program with industry support would be allowed to talk
about such a use. The "freedom of speech" decision can be a very
good thing as long as the individual is held accountable based on
the truthfulness of the information. Even David Kessler when FDA
Commissioner wrote an article that ENCOURAGED the off-label use of
medication as long as there were valid data to support such a use.
Now there may be valid data for non-FDA approved uses; but medical
education speakers are prohibited from discussing the data if the
program has industry support. Let's remove the "gags"..

daryl ruthven

12/05/12

If this stands, the drug companies will use thier most effective
tool - not drug reps, but direct to consumer ads on TV and in
magazines - to drive the customers to the doctor's office with yet
more requests (read - demands) for the drug in the latest ad they
saw on TV. Drug companies are not stupid; they are well aware that
most people don't bother to read and don't bother to think. Tell
them what they wish to hear and they will flock to your product.
Show ads full of happy, healthy, smiling people and the doc will
receive repeated requests for the product. Why are so many TV ads
for pharmaceuticals? Because they work. It will be up to the docs
to hold the line and stick to good medicine. Unfortuantely, we're
not all that good at setting limits, whether it's for unneeded
antibiotics or antidepressants. This issue is not about protecting
free speech. It's about money. Always has been, always will be..

Dr Bob

12/05/12

This does have to be
dichotomous. A
label could have two
columns, one called
Proven Efficacy by
FDA Standards, and
the other Unproven
by FDA Standards.
PEFS and UFS..

Tom Habib, Ph.D.

12/05/12

This is devotion to Friedmann Economics unleased by the hoard of
idealogical believers that promote it. The parallel with Citizens
United is appropriate and frightening. "The market place" is not the
ultimate answer to all of the choices that need to be made in a
civilized society. Corporate greed continues to assault American
welfare with mindless middle class approval. Unbelievable!.

angela devito

12/05/12

Consumers are the
FDA's customers, not
PHARMA.
http://www.scientificamerican.com/article.cfm?id=how-drug-company-money-undermining-science.

anne lindell

12/05/12

Physicians are already often a poor source of information about drugs, because even the best of
them get most of their information about a drug from a profit-driven rep, who's paid by a profit
driven industry. Heaven help us if the drugs reps are given license to make up their own
"cures"..

MD California

12/05/12

I'm a physician. Off-label prescribing is a HUGE percentage of my
prescriptions, yet it would still fall under "standard of care" if
challenged in court if I prescribe a drug for a condition that many
expert colleagues also use.
FREE SPEECH YES. Thought and speech police NO.
But Caveat Emptor. Patients can and should do their own research
and even consider a second opinion.
People can make their own decisions, informed or not. The less the
naysayers, nannies, and regulators control my every action the
better.
Remember we are only talking here about drugs ALREADY FDA APPROVED
for SOMETHING.
If someone is lying ["selling snake oil"] the free market and the
courts can hold them accountable.
Those of you opposed to this are saying you know what's better for
me than I do myself. Such arrogance. No sir..

Delores Kirkwood, RN

12/05/12

Medicine Bear - the FDA does not control vitamins or herbs, etc., or anything that is labeled "Dietary
Supplement".
Ken Pilgren MD - it is difficult to see if you are for or against this decision, but for the rest of the
readers I can assure you that intelligent doctors have been prescribing drugs for off label conditions
for years with reserve when nothing else has helped. So, for that particular reason we do not NEED
this ruling.
RB PharmD - Aspirin has been used for years as you state, and it is OTC, so deemed relatively safe
but still reminds people to consult their doctors for very good reason. If the person has low platelets
and ulcers it would be suicide for the drug pushers (er, Pharmaceutical and RESEARCH people) to tell
someone it is good for this and NOT list the conditions it make worse.
Doctor Bob - great idea, but I'd like to have a website for finding the research on a particular drug
and off label conditions also. Easy tools for the people to make informed decisions about a particular
drug BEFORE taking it.
Anne Lindell - THANK YOU ! NEW Drugs come out these days at a rate of 100 + per month. Doctors
do NOT have time to research each and every one of them. They are at the mercy of greedy drug
manufacturers. Not greedy you say? I can prove they are: They control the market on first time drugs
for a condition with a patent for 5-7 years or so. What happens in the last year or if the drug is
rejected by the public? They find another condition to treat and rename it - so they can still sell it and
get another patent to charge another several years of high cost drugs. The proof is in Prozac. People
stopped taking it in the early 1990's after a couple people committed suicide when starting it and
blamed the drug rather than the Depression. No one would take it. The company redistributed it and
targeted women's PMS with it. Only a doctor or nurse who has been trained to know drugs by their
generic names (rather than the capitalized trade names each company chooses) will pick up on this.
Drug costs will drop drastically if the WHO would require drugs to be identified ONLY by generic
names and they add approved conditions onto the drug that is already available ---> drop in
healthcare costs also..

Mark Sibley, M.D.

12/05/12

''Off - Label'' means using any medical drug or any medical device
in any way the drug company wants to say it....For the umteenth time
I am saddened about the future of patient care......"Off-Label" ads
will now be able to claim anything and everything on TV or in People
Magazine......The viewers and readers will now be told that there is
a magic "CURE" and they need to get it and they will want it....and
demand it.... Especially if the government/somebody else is paying
for it...
"Off-label promotion is not about free speech, it is the medical
equivalent of yelling fire in a crowded auditorium." a Cardiologist
said......
Andrew Kolodny, MD, a New York psychiatrist who has been trying to
reform the use of narcotic painkillers in the U.S., said the
decision was terrible for public health......
"A large portion of Americans already are taking drugs with serious
risks that outweigh the benefits," he said......
"This is going to get much worse," Kolodny said. "It's a safe bet
that health outcomes will decline from medication side effects,
while spending on prescription drugs will continue to rise.".......
Mark A Sibley, MD Team Eye Doctor Florida Eye Center.

robert tilley md

12/05/12

It's easy. If the
drug company markets
a drug for off label
use then make them
liable for bad
outcomes. The
problem is that the
drug companies will
point squarely at
the practitioner for
inappropriate use if
there's a bad
outcome. Make them
carry the can too
and they will be the
first to restrict
their own speech.
Of course we all
know this will never
happen.....

dorothygreen

12/06/12

Point about points
1.Right - the FDA doesn’t approve “dietary supplements”. However –
it seems they or the drug companies they partner with would like
them to. There are several “supplements” or former supplements
that drug companies have latched onto – the trend seems to be to
call them “medical foods” which is really natural stuff in unique
combinations of sometimes larger amounts – say for ‘mild cognitive
dysfunction”. These must be prescribed by a physician. Of course
they are natural nutrients and because of the label they
automatically become more expensive.
2.I don’t see that most respondents here are for the ruling and
that most regard the use by physicians of “off label” to be
acceptable. It is the bloody advertising and deception by Big
Pharma that is the issue and isn’t it? Certainly there are
physicians who take the easy way out by just ordering something
because the patient wants it or they can make some bucks. Or there
are those who are ever so cautious that they deny a patient who has
used an off label drug successfully for years for fear of a
lawsuit -– but it is not most physicians.
3.“NEW Drugs come out these days at a rate of 100 + per month.
Doctors do NOT have time to research each and every one of them.”
Are you sure about that? http://www.pharmalot.com/2011/02/how-many-
new-drugs-did-fda-approve-last-year - More like 21 last year. Big
Pharma does what they can to repackage or impede generics going to
market but they are running out of “magic pills” so they want to
capture the “public” and gain control of supplements. It’s all
about money – that is a given. Perhaps if pictures of presidents
were taken off money it wouldn’t be so easily associated with a
person and rulings by SCOTUS like Citizens United would be
reversed.
4.The idea of a web site with studies provided by Pharma, doctors
and patients experience with “off label” drugs is a terrific idea.
I bet it will have a huge number of hits. Maybe it could be an
extension of KevinMD since WebMD is going off the air – oops I mean
internet.
5.Perhaps if a patient asks a doctor for an off-label that the
doctor does not accept then the patient should be responsible for
providing the research to the doctor and sign a waiver and even if
the doctor suggests there should be a waiver to sign so the doctor
is not held responsible.
6.An even bigger issue might be the burden on insurance companies,
Medicare and Medicaid and ultimately taxpayers for more pill
popped, downed by a sugary soda, with or without the MacMac and
fries. What is the reason for this ruling again? Free lunch?.

jacob teitelbaum MD

12/06/12

FDA approval , which costs upward of $400 million per medication,
is only feasible when a medication is still under patent, and
therefore very expensive. For generic medications (ie-past patent
protection)and natural therapies which are not patentable,it is
almost never possible to get FDA approval because of the economics.
This is so regardless of the strength of the science. I think this
decision can markedly improve patient health, by allowing even low
cost proven treatments to be used.Otherwise, we will continue to
have medical decisions be based on economics(is it worth putting
through a VERY expensive FDA process) rather than sanity or science.

ChasinRabbits

12/06/12

A daryl ruthven and
angela devito. The
most effective
marketing tools the
pharmaceutical
companies have are
the clinical
practice guidelines
that are based on
the pharma sponsored
research and
promoted by pharma
sponsored medical
academia and
researchers. In
other words, your
physician is
following practice
guidelines and
reading medical
studies which
expound why Drug X
is more effective
for a condition. But
these guidelines and
these studies are
sponsored by the
pharmaceutical
companies..

zaur gasimov

12/06/12

Andrew Kolodny, MD, a New York psychiatrist who has been trying to
reform the use of narcotic painkillers in the U.S., said the
decision was terrible for public health.
"A large portion of Americans already are taking drugs with serious
risks that outweigh the benefits," he said.
I think this words, possibly, describe situation with off-label use
of clopidogrel and dual antiplatelet treatment..

jvaljon1

12/06/12

I really don't see the problem here. I go to the Canadian site in
order to find out what drugs are good, which have side effects and of
those, are the side effects worth the risk for ALL conditions
(including off-label) or not? I've always done that. I understand
that Canadians do NOT want to pay for drugs that will make THEIR
treatment costs go up (LOL, that's kind of an A-B-C, right there)!
So I am happy to use the Canadian sites for information as to whether
or not they carry whatever drug's been prescribed for me....and if
they don't, WHY they don't.
Until our FDA becomes more than a shell of its former self, when it
was a robust regulator of safety in both the FOOD AND DRUGS that
Americans consume---we'll be hearing about these egregious cases more
often, rather than less. I'm old enough to remember a time when the
FDA was actually ALLOWED to stand between Americans, and unsafe
and/or dangerous food and drugs---and in those times, whatever
Americans died from, it was NOT adulterated food or unsafely-made
drugs. Drugs manufactured in other countries for US consumption were,
then, subjected to stringent review on the few occasions that they
were allowed into this country. All this took place well before
political currents stripped Americans of the protections to their
food, medicine and water, that they had heretofore enjoyed. I
sincerely hope that I live long enough to see those times return. I'd
like to die knowing that my children will have it at least as good,
as I did, in terms of food, water and medicine safety. I don't think
that's too much to ask..

thpmd

12/07/12

The preamble to the constitution lists six reasons why it was
established. One reason was indeed to "secure the blessings of
liberty", another was to "promote the general welfare". This
decision does not protect the general welfare. We all agree that
off-label use is OK. However, in my opinion, off-label advertising
is dangerous..

ChasinRabbits

12/07/12

@thpmd The Bill of
Rights, Amendment #1
states "Congress
shall make no law
respecting an
establishment of
religion, or
prohibiting the free
exercise thereof; or
abridging the
freedom of speech,
or of the press; or
the right of the
people peaceably to
assemble, and to
petition the
Government for a
redress of
grievances. " To
quote Benjamin
Franklin "Those who
would give up
essential liberty to
purchase a little
temporary safety
deserve neither
liberty nor safety".

pat m

12/10/12

Does this mean we can go back to being courted by big Pharma with
expensive dinners, doubling as drug education?.

tantheman md

12/11/12

There is so much arrogance and condescension dripping in this thread
that I had to wipe my screen. Apparently most think they are smart
enough to know when a med is appropriate but don't give their
doctors the same credit. Agreed, there are so many drugs out there
it's impossible to know everything about all of them. But if you
think a drug rep can sway the physician to use neurontin for uremic
pruritus then the problem isn't with the rep. And if the patient can
strong-arm the physician to use antibiotics for a simple
pharyngitis, again, you have more problems than a rep speaking off-
label.
Many meds are used off-label because the standard stuff hasn't
worked. You can't just make stuff up with nothing to back it up.
Off-label uses are based on small studies or case reports. Tell me
then, what I am supposed to do with my uremic pruritus patient if
the standard antihistamines haven't worked? Just tell her to deal
with it because there are no FDA approved meds because a drug
company hasn't sponsored a study yet???
Furthermore, it seems amazing to me that there are so many corporate
bashers. Don't get me wrong, there are a lot of bad corporations out
there but the tone is so negative. Guaranteed you guys all have
iphones or droids and drive around in a corporation car. What
hypocrisy. Of course corporations are not people but are you telling
me that people collectively cannot do something that individuals
have the right to do? For all you Citizens U haters who blast
corporations as greedy and evil, I'm sure you have no problem taking
their taxes. But wait a second, if they're not people, how can you
tax them? You can't have it both ways..

sandyc

02/17/15

To tantheman md: AWESOME post!!! Could not have been said any better. My thoughts
exactly!.

This survey is a poll of those who choose to participate and are, therefore, not valid statistical samples, but rather a snapshot of what your colleagues are thinking.

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